J-AXEL:在经先前治疗的NSCLC中纳布-紫杉醇 (nab-paclitaxel)与多西他赛至少相当
纳布-紫杉醇是白蛋白结合的无溶剂的紫杉醇纳米颗粒制剂,其各种优点已有描述[1-3]。II期数据显示了经过先前治疗的晚期NSCLC患者的良好结果,ORR为32%,中位PFS为5个月[4]。因此,Nakamura等人报告的随机化III期研究在先前接受过细胞毒性化疗的IIIB/IV期或复发性NSCLC患者中比较了每三周的第1、8和15天100 mg/m2的纳布-紫杉醇与每三周60 mg/m2的多西他赛[5]。 该分析旨在证明纳布-紫杉醇在OS方面的非劣效性。两组均纳入了约250名患者。
显著的PFS和ORR获益
在意向治疗人群中确认了纳布-紫杉醇在OS方面的非劣效性,协议规定的界值为1.25(HR,0.85;95.2% CI,0.68–1.070)。纳布-紫杉醇和多西他赛的中位OS分别为16.2和13.6个月。按照协议规定,在显示出非劣效性之后,测试了在OS方面纳布-紫杉醇相对于多西他赛的优越性。然而纳布-紫杉醇并未显著提高生存率,PFS和ORR均是如此。纳布-紫杉醇和多西他赛的中位PFS为4.2与3.4个月(HR,0.76;p = 0.0042)。在整个组中(n = 459),对治疗有反应的患者占29.9%与15.4%(p = 0.0002;图)。对于具有鳞状组织学的患者(n = 94)为30.4%与10.4%(p = 0.0207),而对于非鳞状NSCLC的患者(n = 365)为29.7%与16.7%(p = 0.0042)。在根据不同年龄、性别、ECOG表现状态、组织学、吸烟状态、疾病阶段、EGFR突变状态和先前治疗的各个亚组中,纳布-紫杉醇的PFS和OS的结果更好。
图: 在ITT人群中并根据组织学,采用纳布-紫杉醇和多西他赛获得的客观缓解率
多西他赛的血液学毒性和纳布-紫杉醇的神经病变
在AE中,采用多西他赛的白细胞减少和中性粒细胞减少的发生率明显高于纳布-紫杉醇(两次比较均p <0.0001),相应地,多西他赛使发热性中性粒细胞减少的发生率显著增加(22.1 %与2.0%)。另一方面,采用纳布-紫杉醇的周围感觉神经病变的发生率更高(55.5%与20.1%,p <0.0001)。作者在总结中强调,对于先前接受过治疗的晚期NSCLC患者,应将纳布-紫杉醇视为标准选择。
参考文献
- Desai N et al., Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res 2006; 12(4): 1317-1324
- Sasaki Y et al., Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci 2014; 105(7): 812-817
- Gradishar WJ et al., Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009; 27(22): 3611-3619
- Sakata S et al., Phase II trial of weekly nab-paclitaxel for previously treated advanced non-small cell lung cancer: Kumamoto thoracic oncology study group (KTOSG) trial 1301. Lung Cancer 2016; 99: 41-45
- Nakamura A et al., Phase III study comparing nab-paclitaxel with docetaxel in patients with previously treated advanced non-small cell lung cancer_J-AXEL. WCLC 2020, OA03.05
© 2020 Springer-Verlag GmbH, Impressum
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